Overview

Decitabine Versus Supportive Care in Adults With Advanced-stage MDS

Status:
Completed
Trial end date:
2003-04-01
Target enrollment:
0
Participant gender:
All
Summary
To compare the safety and efficacy profiles of decitabine to those of supportive care in adults with advanced-stage myelodysplastic syndrome (MDS)
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Astex Pharmaceuticals
Astex Pharmaceuticals, Inc.
Treatments:
Azacitidine
Decitabine
Criteria
Inclusion:

- MDS (de novo or secondary) fitting any of the recognized French-American-British, FAB,
classifications or chronic myelomonocytic leukemia (CMML) with WBC < 12,000/mm3, AND
International Prognostic Scoring System (IPSS) >/= 0.5 as determined by CBC, bone
marrow assessment and bone marrow cytogenetics within 30 days of randomization

- 18 years or older

- Female patients of child-bearing potential must have a negative serum hCG within 24
hours prior to randomization, must practice a medically approved method of birth
control for the past 30 days, and agree to continue this practice for the trial
duration and must not be breast-feeding

- ECOG or WHO performance status of 0-2

- Written informed consent

- Normal renal and hepatic function (creatinine SGPT
Exclusion:

- Acute Myeloid Leukemia (AML) (>/=30% bone marrow blasts) or other progressive
malignant disease

- Patients must have recovered from the toxic effects of prior therapy and must be off
all chemotherapy for a minimum of 4 weeks prior to study entry to the protocol (a
minimum of six weeks for prior nitrosoureas and bone marrow transplantation)

- Ongoing treatment with androgenic hormones, danazol, colony-stimulating factors, or
other agents used to treat MDS within 7 days of study initiation.

- Administration of any investigational agent within the 30 days preceding study
initiation.

- Uncontrolled cardiac disease or congestive heart failure

- Uncontrolled restrictive or obstructive pulmonary disease

- Active viral or bacterial infection

- Superimposed autoimmune hemolytic anemia or thrombocytopenia

- Known positive serology for HIV

- Mental illness or other condition preventing full cooperation with the treatment and
monitoring requirements of the study.